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Implementation of Enhanced Recovery Surgery Program for Pelvic Floor Reconstruction with Transvaginal Mesh

Implementation of Enhanced Recovery Surgery Program for Pelvic Floor Reconstruction with Transvaginal Mesh: A prospective, multicenter, open RCT study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057422
Enrollment
Unknown
Registered
2022-03-12
Start date
2022-03-12
Completion date
Unknown
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic organ prolapse

Interventions

The ERAS protocol group:Implementation of ERAS protocol for patients who underwent TVM repairs
The traditional protocol group:Implementation of traditional protocol for patients who underwent TVM repairs

Sponsors

Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences;National Clinical Research Center for Obstetrics and Gynecology Diseases
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age60~80 years old; 2. For patients with pelvic organ prolapse (POP) who plan to undergo pelvic floor reconstruction with trans-vaginal mesh(TVM) surgery; the indications of TVM surgery must strictly comply with the Chinese guidelines for the diagnosis and treatment of pelvic organ prolapse (2020 Edition): 1)Patients with recurrent symptomatic POP; 2)Patients over 60 years old with newly diagnosed severe prolapse (for Xiehe Pelvic Floor Reconstruction Surgery with TVM, at least stage III (ICS-classification according to POP-Q system) in anterior pelvic compartment, accompany with or without middle compartment; the severity of posterior compartment prolapse no more than stage II. 3. ASA class I - II; 4. Sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Under the age of 60 or over the age of 80; 2. Complicated with gynecological malignant tumor; 3. Acute infection, mental illness and other surgical contraindications; 4. NSAIDs medication contraindications (peptic ulcer, NSAIDs allergy history, aspirin asthma history); 5. Emergency surgery.

Design outcomes

Primary

MeasureTime frame
Postoperative hospital stay;

Secondary

MeasureTime frame
Complications within 30 days after operation;Rehospitalization rate within 30 days after operation;Emergency visit rate within 30 days after operation;Hospitalization expense;First intestinal exhaust time(hours);Postoperative indwelling time of urinary catheter(hours);First assisted walking time, hours;VAS;PGI-I;QoR-15;the incidence of PONV;Residual urine volume after the first catheter removal;The incidence of postoperative morbidity;

Countries

China

Contacts

Public ContactLan Zhu

Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences;National Clinical Research Center for Obstetrics and Gynecology Diseases

zhu_julie@vip.sina.com+86 18612671818

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026